Ocata Therapeutics, Inc. (now owned by Acucela) announced on March 31, 2015 that the company has completed dosing of its Phase 1/2 studies for dry age-related macular degeneration (AMD) and Stargardt’s Macular Degeneration (SMD). A total of 38 patients have been safely dosed. The 200,000 cell cohort, the highest level planned, was successfully completed, paving the way for the next phase of the programs.
“With successful completion of dosing for the phase 1/2 studies at the highest dose level, and following safety data review by the Data and Safety Monitoring Board, we are now able to focus on initiation and execution of our Phase 2 study for AMD and our pivotal study for SMD,” said Paul K. Wotton, President and CEO of Ocata Therapeutics, who added, “We believe that data from the AMD studies will also be an important inflection point for the entire retinal pigment epithelium (RPE) program.”
Ocata has recently received guidance from the European Medicines Agency indicating that its SMD program can be initiated as a pivotal clinical trial. The objective of the SMD trial will be to assess the safety and efficacy of stem cell transplantation compared to an untreated control group. The AMD trial will evaluate the safety of different regimens of immunosuppressive therapy while exploring functional and anatomical outcomes.